Cleared Traditional

K905244 - MODEL LP6 VENTILATOR, MODIFICATION

K905244 is an FDA 510(k) clearance for MODEL LP6 VENTILATOR, manufactured by Aequitron Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K905244 · Aequitron Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
10d
Days
Class 2
Risk

K905244 is an FDA 510(k) clearance for the MODEL LP6 VENTILATOR, MODIFICATION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 30, 1990 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aequitron Medical, Inc. devices

FDA 510(k) Submission Details - K905244

510(k) Number K905244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date November 30, 1990
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K905244.
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991
AIROX AXR. 1A
K901953 · Ferguson Medical · Jan 1991
CONTINUOUS VOLUME VENTILATOR MODEL LP10
K903010 · Aequitron Medical, Inc. · Nov 1990
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990
NEWPORT WAVE VENTILATOR MODEL E200
K901785 · Newport Medical Instruments, Inc. · Aug 1990
BEAR CEM CONTROLLER
K900637 · Bear Medical Systems, Inc. · Aug 1990